Medivir: New Phase III Data from Once-Daily Simeprevir Presented at the Conference of the Asian Pacific Association for the Study of the Liver (APASL)

Medivir AB today announced that new phase III data for the once-daily
protease inhibitor simeprevir have been presented at the Conference of
the Asian Pacific Association for the Study of the Liver (APASL) in
Brisbane, Australia.

· In the PROMISE phase III trial of prior relapse patients, a subgroup
analysis of genotype 1b patients demonstrated that 86 percent (ITT
analysis) of these patients achieved SVR12 when treated with simeprevir
in combination with PegIFN/RBV, compared to 43 percent when treated with
placebo in combination with PegIFN/RBV.

"We are very pleased to report on the successfully completed phase III
ATTAIN study demonstrating non-inferiority of simeprevir compared with
telaprevir, and a superior safety profile in this difficult to treat
patient group. Moreover, the further analysis of the genotype 1b HCV
patients of the phase III studies QUEST-1, QUEST-2 and PROMISE
demonstrated very high SVR12 rates supporting the strength of simeprevir
as a treatment option for this large patient population" says Charlotte
Edenius, EVP Development, Medivir AB.

ATTAIN

About the ATTAIN study

The multicenter phase III clinical study of treatment-experienced
genotype 1 HCV patients partial- and null-responder patients to at least
one previous course of PegIFN/RBV therapy called the ATTAIN study is a
randomized, double-blind, two-arm study. In the trial, 771 patients were
randomized (1:1) to treatment with either 150 mg of simeprevir once
daily plus PegIFN/RBV or 750 mg of telaprevir three times per day plus
PegIFN/RBV for 12 weeks, followed by 36 weeks of PegIFN/RBV alone.

Results from the ATTAIN study

Results from ATTAIN show that simeprevir achieved its primary endpoint
of non-inferiority to telaprevir in treatment-experienced HCV patients
and demonstrated a superior safety profile. In the study, 54 percent of
chronic HCV genotype 1 prior partial- and null-responder patients
treated with simeprevir administered once daily in combination with
pegylated interferon and ribavirin achieved the primary endpoint of
sustained virologic response 12 weeks after end of treatment (SVR12)
compared to 55 percent of patients treated with telaprevir administered
three-times daily plus pegylated interferon and ribavirin.

SVR12 rates across patient subgroups were generally similar between the
simeprevir and telaprevir arms, including among patients with the HCV
genotype 1a Q80K mutation. Twenty-seven percent of patients with the HCV
Q80K mutation achieved SVR12 in the simeprevir arm versus 26 percent in
the telaprevir arm. The study also found that 60 percent of patients
with the IL28B CC genotype, 55 percent of CT patients and 48 percent of
TT patients in the simeprevir arm achieved SVR12, versus 67, 57 and 50
percent of patients in the telaprevir arm, respectively.

The most common adverse events during the first 12 weeks of treatment
occurred at a consistently lower frequency in the simeprevir treatment
arm compared to the telaprevir treatment arm, including pruritus (31
percent versus 43 percent), fatigue (32 percent versus 38 percent),
headache (25 percent versus 29 percent), anemia (13 percent versus 37
percent), and nausea (17 percent versus 28 percent). Thirty-four percent
and 18 percent of simeprevir-treated patients experienced on-treatment
failure and relapse, respectively, compared to 32 percent and 17 percent
of telaprevir-treated patients, respectively. Two percent of patients in
the simeprevir arm and eight percent of patients in the telaprevir arm
discontinued treatment early due to an adverse event. Serious adverse
events were reported in two percent of patients in the simeprevir arm
and nine percent of patients in the telaprevir arm.

In a pooled analysis of the QUEST-1 and QUEST-2 studies, 89 percent of
treatment-naïve genotype 1b HCV patients treated with simeprevir in
combination with pegylated interferon and ribavirin and met the criteria
for response guided therapy (94 percent) achieved SVR12 compared to 53
percent of patients treated with placebo in combination with pegylated
interferon and ribavirin (ITT-analysis 85 and 53 percent, respectively).
In patients typically considered difficult to treat, 71 percent of
patients with the IL28B TT genotype and 78 percent with METAVIR F3-F4
scores achieved SVR12 in the simeprevir arm. Two percent of patients in
each treatment arm discontinued treatment with simeprevir or placebo
early due to an adverse event.

An analysis of the PROMISE study found that 89 percent of prior-relapser
genotype 1b HCV patients treated with simeprevir in combination with
pegylated interferon and ribavirin and met the criteria for response
guided therapy (95 percent) achieved SVR12 compared to 43 percent of
patients treated with placebo in combination with pegylated interferon
and ribavirin (ITT-analysis 86 and 43 percent, respectively). In
patients typically considered difficult to treat, 68 percent of patients
with the IL28B TT genotype and 84 percent with METAVIR F3-F4 scores
achieved SVR12 in the simeprevir arm. No patients discontinued treatment
with either simeprevir or placebo due to adverse events during the
entire treatment phase in this analysis of PROMISE.

Medivir is required under the Securities Markets Act to make the
information in this press release public. The information was submitted
for publication at 08.30 CET on 17 March 2014.

About Simeprevir

Simeprevir is an NS3/4A protease inhibitor jointly developed by Janssen
R&D Ireland and Medivir AB and indicated for the treatment chronic
hepatitis C infection in combination with pegylated interferon and
ribavirin in HCV genotype 1 infected patients with compensated liver
disease, including cirrhosis.

Janssen is responsible for the global clinical development of simeprevir
and has exclusive, worldwide marketing rights, except in the Nordic
countries. Medivir AB will retain marketing rights for simeprevir in
these countries under the marketing authorization held by Janssen-Cilag
International NV. The treatment was approved for the treatment of
genotype 1 hepatitis C in September 2013 in Japan and in November 2013
in Canada and USA. A Marketing Authorisation Application was submitted
to the European Medicines Agency (EMA (News - Alert)) in April 2013 by Janssen-Cilag
International NV seeking approval of simeprevir for the treatment of
genotype 1 or genotype 4 chronic hepatitis C. This application is under
review by the EMA.

Simeprevir is also being studied in several interferon-free regimens
using selected combinations of direct-acting antiviral agents with
different mechanisms of action. To date, more than 3,700 patients have
been treated with simeprevir in clinical trials.

About Medivir

Medivir is an emerging research-based pharmaceutical company focused on
infectious diseases. Medivir has world class expertise in polymerase and
protease drug targets and drug development which has resulted in a
strong infectious disease R&D portfolio. The Company's key pipeline
asset is simeprevir, a novel protease inhibitor for the treatment of
hepatitis C that is being developed in collaboration with Janssen R&D
Ireland. The company is also working with research and development in
other areas, such as bone disorders and neuropathic pain. Medivir has
also a broad product portfolio with prescription pharmaceuticals in the
Nordics.

For more information about Medivir AB, please visit the Company's
website: www.medivir.com